The following data is part of a premarket notification filed by Laseroptek Co. Ltd. with the FDA for Helios Ii Q-switched Nd:yag Laser System.
| Device ID | K083203 |
| 510k Number | K083203 |
| Device Name: | HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASEROPTEK CO. LTD. 22750 HAWTHORNE BLVD. SUITE 211 Torrance, CA 90505 |
| Contact | Phillip Cheon |
| Correspondent | Phillip Cheon LASEROPTEK CO. LTD. 22750 HAWTHORNE BLVD. SUITE 211 Torrance, CA 90505 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-30 |
| Decision Date | 2009-04-28 |
| Summary: | summary |